MetaOx, Optical Monitor of Metabolic Rate of Oxygen Consumption

MetaOx，耗氧代谢率光学监测仪

• 批准号: 8532949
• 负责人: Beniamino Barbieri
• 金额: $ 20.87万
• 依托单位: ISS, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-20 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8532949
• 关键词: Acute; Adult; Animal Model; Animals; Antiepileptic Agents; Biomedical Engineering; Blood flow; Boa; Boston; Brain; Brain Injuries; Bumetanide; Cardiac Surgery procedures; Caring; Cerebrovascular Circulation; Cerebrum; Clinic; Clinical; Collaborations; Computer software; Consumption; Critical Illness; Cyprinus carpio; Data Analyses; Data Quality; Detection; Development; Devices; Diagnosis; Diffuse; Diffusion; Disease; Electroencephalography; Energy Metabolism; Equilibrium; Europe; Evolution; Feedback; Frequencies; General Hospitals; Goals; Grant; Head; Health; Hemoglobin; Hospitals; Hour; Human; Hypercapnia; Infant; Injury; Intervention; Joints; Language; Magnetic Resonance Imaging; Marketing; Massachusetts; Measurement; Measures; Medical Staff; Metabolic; Metabolism; Monitor; Morbidity - disease rate; Motor; Neonatal; Neonatal Intensive Care Units; Neonatology; Neurons; Newborn Infant; Optics; Outcome; Oxygen; Oxygen Consumption; Oxygen saturation measurement; Patients; Pediatric Hospitals; Pennsylvania; Performance; Pharmaceutical Preparations; Phase; Philadelphia; Pilot Projects; Population; Positron-Emission Tomography; Research; Research Personnel; Risk; Role; Safety; Seizures; Signal Transduction; Small Business Innovation Research Grant; Spectrum Analysis; System; Technology; Testing; Time; Tissues; Training; Translating; Translations; Ultrasonography; Universities; Woman; Work; clinically relevant; commercialization; data acquisition; design; fish Carp; healthy volunteer; human subject; improved; indexing; innovative technologies; instrument; instrumentation; natural hypothermia; neonate; novel; optical imaging; prototype; relating to nervous system; response; screening; systems research; tool

DESCRIPTION (provided by applicant): ISS Inc., in collaboration with Dr. Franceschini of the Massachusetts General Hospital and Dr. Yodh of the University of Pennsylvania, proposes to develop and construct the prototype of a novel instrument to monitor cerebral oxygen metabolism (CMRO2) that combines a frequency-domain near-infrared tissue oximeter (FDNIRS) and a diffusion correlation spectroscopy (DCS) device. Combining FDNIRS and DCS will enable us to measure cerebral hemoglobin oxygenation (SO2) and an index (BFi) of cerebral blood flow (CBF) to estimate CMRO2. Our clinical collaborators Dr. Ellen Grant of Children's Hospitals in Boston, and Dr. Daniel Licht of Children's Hospital of Philadelphia will advise us on optimizing the device for the neonatal ICU clinical setting. The ability to rapidly an accurately assess cerebral metabolism at bedside in neonates is critical to improving patient management in neonatology. Currently there is no bedside tool that can accurately screen for brain injury, monitor injury evolution or assess response to therapy. Head ultrasounds are notoriously insensitive and nonspecific, EEG serves a complementary role, and MRI is too expensive and time-consuming to be used for screening or monitoring, and involves unnecessary risks of destabilizing critically ill infants who must be transported to the MRI suite. Conventional NIRS oximetry has failed to become a routine clinical tool in neonatology due to the poor sensitivity of SO2 in detecting brain injury hours after the insult, when equilibrium between oxygen delivery and consumption is reestablished. The direct measure of cerebral oxygen utilization we propose to measure with this novel instrument will provide higher sensitivity to detect brain injury and the ability to monitor normal and abnormal brain development. If successful, this device will allow for real-time interventions and thus could improve clinical outcome. Our long-term plans encompass the commercialization of the first FDNIRS/DCS cerebral metabolism monitoring system. In phase I we will build the first commercial prototype, start to develop unified acquisition and data analysis software, and test this new system in phantoms and adult human subjects. We will then perform a pilot study in newborns and compare infants with seizure activity confirmed by EEG with healthy controls, to validate the hypothesis that a measure of oxygen consumption is better able to diagnose brain damage than measure of hemoglobin oxygenation. While CMRO2 monitoring has been performed previously in a research setting, by combining ISS FDNIRS systems with lab-built DCS instrumentation, these measurements have required highly trained operators and data analysis by optical imaging experts. Our goal is to transform these cumbersome research systems into a more robust turnkey device that will enable medical staff to obtain clinically and relevant measurements at the bedside. After completion of the Phase I portion of the project, we will proceed with Phase II, during which we plan to refine the system and start demonstrating the clinical relevance of our CMRO2 measurements in three hospitals (Brigham and Women's and Children's Hospitals in Boston, and Children's Hospital of Philadelphia with Dr. Daniel Licht). If the plan is accepted in its entirety, we expect to complete development of the FDNIRS/DCS system, which we call MetaOx, within the projected four-year period.

描述（由申请人提供）：ISS Inc.，与马萨诸塞州总医院的Franceschini博士和宾夕法尼亚大学的Yodh博士合作，提出开发和构建一种新型仪器的原型，以监测脑氧代谢（CMRO 2），该仪器结合了频域近红外组织血氧计（FDNIRS）和扩散相关光谱（DCS）设备。结合FDNIRS和DCS将使我们能够测量脑血红蛋白氧合（SO2）和脑血流量（CBF）指数（BFi），以估计CMRO 2。我们的临床合作者波士顿儿童医院的Ellen Grant博士和费城儿童医院的丹尼尔Licht博士将建议我们优化新生儿ICU临床环境的设备。在床旁快速准确评估新生儿脑代谢的能力对于改善新生儿疾病的患者管理至关重要。目前还没有床边工具可以准确地筛查脑损伤，监测损伤演变或评估对治疗的反应。头部超声波是出了名的不敏感和非特异性，EEG起着补充作用，MRI太昂贵和耗时，不能用于筛查或监测，并且涉及不必要的风险，使必须被运送到MRI室的危重婴儿不稳定。 传统的近红外线血氧饱和度测定法未能成为一个常规的临床工具，在颅脑损伤后的几个小时，当氧的输送和消耗之间的平衡重建时，由于在检测脑损伤的SO2的敏感性差。我们建议用这种新型仪器直接测量脑氧利用率，这将为检测脑损伤提供更高的灵敏度，并能够监测正常和异常的脑发育。如果成功，该设备将允许实时干预，从而可以改善临床结果。我们的长期计划包括第一个FDNIRS/DCS脑代谢监测系统的商业化。在第一阶段，我们将建立第一个商业原型，开始开发统一的采集和数据分析软件，并在幻影和成人受试者中测试这个新系统。然后，我们将在新生儿中进行一项试点研究，并将脑电图证实癫痫发作活动的婴儿与健康对照组进行比较，以验证氧耗测量比血红蛋白氧合测量更能诊断脑损伤的假设。虽然CMRO 2监测以前已经在研究环境中进行，通过将ISS FDNIRS系统与实验室建造的DCS仪器相结合，但这些测量需要训练有素的操作员和光学成像专家的数据分析。我们的目标是将这些笨重的研究系统改造成一个更强大的交钥匙设备，使医务人员能够在床边获得临床和相关的测量。在项目的第一阶段完成后，我们将继续进行第二阶段，在此期间，我们计划完善该系统，并开始在三家医院（波士顿的Brigham妇女和儿童医院以及费城儿童医院与丹尼尔Licht博士）证明我们的CMRO 2测量的临床相关性。如果该计划全部被接受，我们预计将在预计的四年内完成FDNIRS/DCS系统的开发，我们称之为MetaOx。